NCT07876700

Brief Summary

The goal of this basic neuroscience study is to learn whether visual feedback of brain activity can help improve arm and hand recovery in people who recently had a stroke. The study will also examine whether this type of training is practical to use during early stroke rehabilitation. Researchers will compare two groups of participants. Both groups will practice reaching for and grasping a cup, either by physically performing the movement or imagining the movement. One group will receive visual feedback showing their brain activity during practice. The other group will complete the same practice without seeing this feedback. Participants will be randomly assigned to one of these groups. The study will include 60 participants who had a stroke and who have weakness in one arm. Participants will complete 8 in-person sessions over 2 weeks. The first and last sessions will include tests of arm function, disability, quality of life, and brain activity. The 6 sessions in between will involve repeated movement or imagined movement practice. During the sessions, researchers will use functional near-infrared spectroscopy (fNIRS), a non-invasive brain imaging tool that shines light into the scalp to measure changes in brain activity. Small sensors placed on the skin of the arm and hand will also be used to measure muscle activity.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
35mo left

Started Dec 2026

Typical duration for not_applicable stroke

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

2.8 years

First QC Date

September 29, 2026

Last Update Submit

October 8, 2026

Conditions

Stroke

Keywords

rehabilitationexercisearmupper limb

Outcome Measures

Primary Outcomes (1)

  • functional Near Infrared Spectroscopy (fNIRS) amplitude over the motor cortex

    brain activity

    Session 8 (up to 6 months post stroke)

Secondary Outcomes (8)

  • National Institutes of Health Stroke Scale

    Pre-intervention

  • Fugl-Meyer Upper Extremity

    Session 8 (up to 6 months post stroke)

  • Action Research Arm Test

    Session 8 (up to 6 months post stroke)

  • EuroQol Five Dimensions

    Session 8 (up to 6 months post stroke)

  • Modified Rankin Scale

    Session 8 (up to 6 months post stroke)

  • +3 more secondary outcomes

Study Arms (2)

neurofeedback group

EXPERIMENTAL

This group will receive visual feedback of the fNIRS signal

Other: fNIRS-neurofeedback

Control group

ACTIVE COMPARATOR

This group will not receive visual feedback

Other: Control

Interventions

fNIRS-neurofeedbackOTHER

This group receives visual feedback of the fNIRS signal

neurofeedback group
ControlOTHER

Control group

Control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke patients in the subacute phase
  • upper extremity hemiparesis (\< or =4/5 manual muscle grade in at least one of the major upper extremity muscles)
  • Modified Rankin Scale (mRS) score of \<2 pre-stroke
  • Able to communicate in English
  • Able to comprehend instructions and provide informed consent

You may not qualify if:

  • cognitive deficits
  • have another known neurological or serious medical condition (e.g., Parkinson's, active cancer, etc.)
  • Present with severe receptive aphasia which would compromise their ability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Central Study Contacts

Sue Peters, PT, PhD

CONTACT

519-646-6100sue.peters@uwo.ca

Sean Lai

CONTACT

519-646-6100slai222@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2026

First Posted

October 15, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

October 15, 2026

Record last verified: 2026-10